COPPER: An Adaptative Design, Randomized, Multicenter, Controlled, Double-Blinded Exploratory Trial, Evaluating the Management of Incontinence-Associated Dermatitis Using Copper Containing Absorbing Incontinence Products
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 150
- 主要终点
- Proportion of non-progressing IAD 14 days
研究概览
简要总结
As there are currently no evidence on the benefit of absorbing incontinence products with copper to stabilize IAD in the elderly, thus, this study will assess the capacity and safety of an absorbing incontinence products with a copper-based substance for the management of adults with incontinence-associated dermatitis, compared to an absorbing incontinence products with no substance. This approach may contribute for IAD management arsenal, since clinical evidence on the efficiency of products available in the market to manage IAD is frail, as seen in systematic reviews mentioned above. We believe copper, as a barrier product, has the potential to perform well in this clinical setting of IAD, as it performed well in other settings.
详细描述
This study adopts an exploratory trial design with an adaptive approach. It is randomized, multicenter, controlled, and double-blinded, with parallel groups and blinded outcome adjudication. The study hypothesis suggests that incontinence products infused with copper-based substances may provide superior stabilization of IAD compared to control products.
The primary objective of the study is to evaluate the effectiveness of absorbing incontinence products containing a copper-based substance in stabilizing incontinence-associated dermatitis (IAD) in adults with moderate to severe urinary and/or fecal incontinence. This will be compared against standard absorbing incontinence products without copper-based substances, with both groups receiving usual care. Secondary objectives include assessing improvements in pain within 14 and 28 days, evaluating quality of life improvements over 28 days, and measuring changes in skin health scores from baseline to 14 and 28 days.
Participants will be adults aged 60 years or older, experiencing moderate to severe urinary and/or fecal incontinence. Eligibility will be determined using specific scales outlined in the study rationale. Recruitment will target individuals in long-term care facilities or hospital wards located within São Paulo municipality and its metropolitan area in Brazil. Feasibility assessments will be conducted at each site during an initial visit. Sites deemed suitable will then proceed with participant recruitment.
This study seeks to address critical aspects of managing IAD, particularly through innovative copper-based products. By focusing on clinical endpoints such as pain reduction, quality of life enhancements, and improvements in skin health, the trial aims to provide evidence supporting the potential benefits of copper-infused incontinence products over traditional alternatives.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability and capability to participate in the study and follow study procedures as determined by the investigator.
- •With moderate or more intense urinary (ISI ≥ 3) and/or fecal incontinence (Pescatori et al. (B1, B2, B3, C1, C2, C3);
- •Current users of absorbing incontinence products.
- •Diagnosed with incontinence-associated dermatitis GLOBIAD 1A or 2A.
排除标准
- •Incontinence-associated dermatitis GLOBIAD 1B or 2B;
- •The subject who knows about allergy or a history of an adverse reaction to product ingredients or to any topical preparations or skincare products;
- •The subject who has an active skin condition or a history of recurrent skin conditions, except IAD, that may affect IAD healing;
- •The subject who was treated in the previous week with systemic or topical agents (except for IAD) that may affect IAD healing process (e.g., steroids);
- •Subject with a score < 10 in Mini Nutritional Assessment - Short Form;
- •Subjects with diabetes.
结局指标
主要结局
Proportion of non-progressing IAD 14 days
时间窗: 14 days
Proportion of non-progressing IAD after 14 days from randomization start by GLOBIAD criterion.
次要结局
- Proportion of non-progressing IAD 28 days(28 days)
- Quality of life SF12(28 days)
- Pain assessment(14 and 28 days)
- Skin health by skin health assessment tool(14 and 28 days)
- Time to resolution of IAD(From enrollment to resolution, mean of 4 to 7 days)
- Reoccurrence of IAD(From resolution of the first episode of IAD to the 28th day)